QA Manager GCP - Basel
- Employer
- Umbilical Life
- Location
- Canton of Basel-Stadt (CH)
- Salary
- Negotiable
- Start date
- 17 Sep 2019
- Closing date
- 17 Oct 2019
Job Details
My client are an extremely exciting company that has a start-up feel but with Large Pharma levels of investment and infrastructure. This a 12 month very well paid contract based on site in Basel.
This role will involve managing the QA for a range of clinical trials going on around Europe and on-site. You will be assisting the Clinical Project Manager to ensure quality remains at the highest throughout the different phases. There will also be a portion of your role which involves site visits and audits.
Please get in touch as soon as possible as this is an urgent contract role. I have put some information below about the responsibilities of this role.
Job Description
- Work as per the defined strategy for the global clinical audit program (e.g. site, vendor, process)
- Plan, perform, and report audits (e.g. site, vendor, process) using considerable latitude in determining best practice and approach
- Develop own area of ICH-GCP expertise with limited supervision (e.g. self-training, knowledge acquisition by reading/assisting to course identify by himself)
- Lead the preparation, facilitation and follow up of inspections by national and international regulatory authorities
- Facilitate the CAPAs elaboration and follow-up
- Escalate serious / continuing non-compliance issues as appropriate
- Make a significant contribution to ensure that QS documents creation and management is done in accordance with ICH-GCP requirements / regulations
- Contribute to process improvements and trouble shooting
- Maintain awareness / expertise in international ICH-GCP requirements
- Provide leadership and direction on ICH-GCP related activities / issues
- Work closely with CRO Clinical Trial Teams
- Support CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical
Quality Management System and clinical trial framework by different ways (e.g. provide training to CD staff, feedback to ICH-GCP questions)
- Highly contribute to develop/improve CQA tools and processes
- Represent CQA in internal and external meetings and particularly represent Team Leader CQA when he/she is not available
- Perform any other CQA task that could help to achieve a high adherence to ICH-GCP requirements
Candidate Requirements
- Bachelor degree or equivalent education/degree in (life) sciences or healthcare
- Experienced in Clinical Research & Development. At least 6 years of experience in pharmaceutical industry/health authority with at least 3 years of experience
in Quality Assurance / Auditing (QA) within the ICH-GCP environment.
- In-depth knowledge of global ICH-GCP requirements and pharmaceutical industry practices
- Ability to work as a team player and independently
- Reliable, conscientious, agile/flexible
- Proven record of excellent problem solving, risk analysis and negotiation skills
- Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource)
- Experience in medical device and/or combination product will be an added value
- Strong writing, communication and listening skills
- Experience in international cross-cultural relations
- Very good English knowledge (written and spoken)
Company
Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering.
Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.
With nearly 75 years of workforce industry experience between us we know a lot, but not everything.
We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.
- Website
- http://umbilical.co/
- Telephone
- 011 6 461 0070
- Location
-
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom
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